LYMEPOLICYWONK: Embers Monkey Trials Part 4. Lab Tests Fail to Detect Lyme Disease.

Byldoadmin

All antibody lab tests, like the C6, are indirect measures of infection.  Rather than detecting the bacteria directly, they detect antibodies produced by the patient’s immune system to bacteria. When the patient’s immune response fails to detect infection, the antibodies that the lab tests measures are not produced.  This results in a negative lab test.

The Embers study compared the C6 antibody test with more direct measures of infection, including PCR, culture, immunofluorescence (visualization of spirochetes in inflammatory lesions), and something called xenodiagnosis.  (Xenodiagnosis allows uninfected ticks to feed on the monkey and then examines the ticks for Bb. The use of xenodiagnosis in humans in controversial.) The Embers study found that even when there was direct evidence of persistent infection found through invasive tissue sampling, the C6 blood test failed to detect it. This suggests that the C6 test should not be used for diagnosis since with the passage of time those who have the infection will test negative and anyone previously treated with antibiotics will test negative.

The researchers believed that the reason the C6 test became insensitive in the treated monkeys was that the number of spirochetes may have been reduced or had become a dormant form of bacteria that does not produce the antigens necessary for the C6 test to be accurate.  No explanation was offered for the insensitivity of the test on 50% of the non-treated monkeys.

The insensitivity of the C6 antibody test may apply to other antibody tests as well. This is important because it may explain why patients with persistent manifestations of Lyme disease often test negative on lab tests.  Embers suggests that patients may have persistent infection even if they test negative on an antibody lab test.

This is consistent with the fact that other commercial antibody lab tests in Lyme disease fail to detect disease roughly 50% of the time.  If lab tests are this insensitive–in fact, no better than a coin toss for diagnosing Lyme disease, they should not be required for diagnosis.  Yet, this is what the IDSA Lyme guidelines require.  The Embers study suggests that this requirement will leave many patients who have Lyme disease undiagnosed and untreated.

This article is part of a series of reviewing the Embers findings for treatment of chronic and early disseminated Lyme disease as well as the effectiveness of the C6 antibody test. You can find these other posts here:

Part 1–New study shows Lyme persists in monkeys

Part 2–Treatment and Persistence

Part 3–IDSA 28-day treatment protocol fails to clear infection

Part 4–Lab tests fail to detect Lyme disease

Part 5–Of mice and men and monkeys

Read the journal article here.

References:

Embers ME, Barthold SW, Borda JT, Bowers L, Doyle L, Hodzic E, et al. Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection. PLoS ONE. 2012;7(1):e29914.

Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, et al. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134

The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at lbjohnson@lymedisease.org.

Similar Posts

  • LYMEPOLICYWONK: Artful Dodgers, 1,2,3 : the IDSA, the NIH and the IOM Makes Three

    What do Representatives Chris Smith and Frank Wolf have in common? They know how to ask the right people hard questions. What do the IDSA, the NIH, and the IOM have in common? They’ve honed the skill of the artful dodger. Representatives Smith and Wolf want to know why the NIH “stepped back” from its charge to run a state of the science conference and handed that hot potato to the IOM. One big difference between the NIH process and the IOM process? The NIH process considers bias a conflict of interest, meaning IDSA folks wouldn’t be sitting on an NIH panel. But, drum roll. . .the IOM permits panels to be biased and coincidentally has a panel that consists almost exclusively of IDSA folks, 4 of 6 panel members. Oh, and one more thing, the IOM is not technically considered to actually be ‘the government’. This is a picture perfect example of plausible deniability. The NIH didn’t stack a panel. The IOM did with IDSA folks. But, hey, they like bias and they are not accountable, are they? A copy of the letter from Representatives Smith and Wolf to Dr. Francis Collins of the NIH together with Collins response can be downloaded at the bottom of this blog post.

  • CALDA, LDA and TFL Press Release on IDSA Hearing

    CALDA, the national Lyme Disease Association and Time for Lyme have issued a joint press release regarding the IDSA Lyme review hearing, which is schedule for July 30th in Washington D.C. The release highlights the growing opposition to the IDSA guidelines, the importance of acknowledging the full spectrum of science in Lyme disease, and the importance of permitting clinical judgment and treatment options for patients. Concerns are also raised about the current process, which Attorney Lorraine Johnson points out is not impartial because IDSA controls the process and has selected both the panel members and those who may present before the panel. Of critical importance is that fact that no physicians who treat chronic Lyme disease were selected to sit on the panel. The testimony will be aired live over the internet on July 30th.

  • LYMEPOLICYWONK: IOM Conference calls: A Phone to Nowhere?

    I have to say, I have not heard encouraging things about the IOM process. Most folks think the IDSA simply plucked a friendly forum to reaffirm its beleaguered Lyme guidelines and the tainted Lyme review panel process. The big question is: Does this process have any substance or is it just a matter of going through the motions? Is anybody listening on these "listening" phone calls? Is the IOM offering to listen to anyone who cares?

  • LYMEPOLICYWONK: Intellectual Conflicts of Interest–A New Way to Smell a Rat?

    Here’s an interesting approach to conflicts of interests offered by one of the fathers of evidence based medicine, Dr. Gordon Guyatt. The topic was guideline development and the interests of those serving on a guideline panel in having their pet theories and research promoted in the guidelines. Why is this important to researchers? It helps further the academic careers of researchers when their work is cited, referred to and used as the foundation for creating treatment guidelines. There is a dynamic tension between the use of expertise and the potential bias expertise may bring to the table. Those of us in the Lyme community are only too familiar with the fact that the IDSA guidelines were developed by academic researchers and that references to their own research dominate the guidelines. Being tied to a theory that your research has advanced creates a bias towards reinforcing that theory in the selection of evidence cited, the evaluation of that evidence, and the development of guideline recommendations that confirm that bias. Guyatt’s perspective is novel and interesting. In his mind the way to manage this bias is not to exclude the researchers from sitting on the guideline panel but to limit their ability to misuse their power to further their own ends. Hence, those with what he called a primary conflict of interest are precluded from chairing a guideline panel, drafting recommendations and voting on them and even the ranking of evidence. Read how he defines an intellectual conflict of interest and how he would restrict participation in guideline development by those with intellectual bias.

  • LYMEPOLICYWONK: Impure Science—the Fine Art of Blowing Smoke

    Have you read the LA Times op-ed that ran on December 16 by Daniel Sarewitz and Samuel Thernstrom? The piece is called “Impure Science”. It is blazingly good. The focus is on the global warming debate and recent suggestions of bias in email exchanges from one side of that controversy that were disclosed to the press. The take-home points though apply to any area, like Lyme, where there is divided science and polemic viewpoints. While the debates are shrouded in science, the real debate is not about science, but stakeholder viewpoints. When science is subject to interpretation by different stakeholder, the question is who controls the mike?

  • LYMEPOLICYWONK: Bogus Grassroots Groups – Who’s Who and What’s What with the American Lyme Disease Foundation (ALDF)

    It’s easy to get confused. You have the “Lyme Disease Foundation” (LDF), and you have the “American Lyme Disease Foundation” (ALDF). They both sound like patient advocacy organizations, but they are not. Welcome to the world of astroturf organizations—false grass roots organizations where names are intended to sound alike and offer no hint of special interests behind them. Until its recent demise, the LDF was a patient organization that was founded in 1988. And, the ALDF? Well, the ALDF was founded in 1994. It is a stealth front group for the Infectious Diseases Society of America (IDSA). Stealth front groups are seemingly independent third-party organization designed to deceive audiences as to the sponsor’s actual intentions.